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FDA 510(k), K130132, BABYLANCE HEEL INCISION DEVICE
FDA 510(k), K130132, BABYLANCE HEEL INCISION DEVICE
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510(K) Number: K130132
Device Name: BABYLANCE HEEL INCISION DEVICE
Manufacturer: MEDIPURPOSE PTE. LTD.
Device Classification Name: single use only blood lancet with an integral sharps injury prevention feature
Regulation Number: 878.4850
Classification Product Code: FMK
Date Received: 01/18/2013
Decision Date: 02/11/2013
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BABYLANCE HEEL INCISION DEVICE
Manufacturer: MEDIPURPOSE PTE. LTD.
Device Classification Name: single use only blood lancet with an integral sharps injury prevention feature
Regulation Number: 878.4850
Classification Product Code: FMK
Date Received: 01/18/2013
Decision Date: 02/11/2013
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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